Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT01718158
Eligibility Criteria:
Inclusion Criteria:
* Patients chronically infected with HCV Genotype-1b
* Naïve to prior treatment or documented evidence of relapse after completion of the prescribed duration of treatment (duration may be 24 or 48 weeks, to be determined based upon local guidelines)
* HCV RNA viral load ≥100,000 IU/mL at screening
* Patients with compensated cirrhosis are permitted
Exclusion Criteria:
* Infection with Hepatitis C virus (HCV) other than Genotype-1b
* Positive Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus (HIV)-1/HIV-2 antibody test at screening
* Evidence of chronic liver disease caused by diseases other than chronic HCV infection
* Current evidence of or history of variceal bleeding, hepatic encephalopathy, or ascites requiring diuretics or paracentesis or evidence of any of these findings on physical examination performed at screening
* Current or known history of cancer (except adequately treated in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to screening
* Current evidence or known history of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
* Laboratory values:
1. Hemoglobin \<12.0 g/dL (males) or \<11.0 g/dL (females)
2. Platelets \<90,000/mm3
3. Total serum bilirubin ≥2 mg/dL (unless due to Gilbert's disease)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01718158
Study Brief:
Protocol Section:
NCT01718158